Fractional Laser Assisted Topical Anesthesia

March 11, 2019 updated by: Netherlands Institute for Pigment Disorders

Fractional CO2 Laser Assisted Topical Articaine Anesthesia vs. Topical EMLA Administration: a Randomized Controlled Study

The purpose of this study is to assess the efficacy of skin anesthesia using fractional laser assisted delivery of articaine hydrochloride 40 mg/ml and epinephrine 10 µg/ml solution (AHES) compared to standard anesthesia with topical eutectic mixture of lidocaine 25 mg/g and prilocaine 25 mg/g cream (EMLA cream) prior to ablative fractional laser treatment of acne scars and traumatic scars.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Rationale: In dermatology, many minor surgical and laser procedures are carried out under local anesthesia of the skin. Anesthesia using topical formulations is time consuming, as the anesthetic has to be applied at least one hour before treatment, and is often only partially effective. On the other hand infiltration anesthesia is often associated with discomfort and is not tolerated by patients who are for example needle phobic. In the past years, Haedersdal and colleagues have shown that the penetration of various topically applied substances, including photosensitizers, into the skin can be enhanced and accelerated by pretreatment of the skin with a fractional laser, creating a pattern of microscopic ablation craters.1 This improvement in drug penetration is regardless of ablation crater depth.2 There is limited evidence that transepidermal lidocaine absorption can be increased by fractional laser pretreatment.3, 4 These findings might suggest that local anesthesia of the skin may be achieved by applying an anesthetic topically on a skin surface pretreated with a fractional laser. The investigators of the present study hypothesize that fractional laser assisted delivery of topical anesthetics might give a faster and better anesthetic effect, than treatment with the standard treatment of topical anesthesia.

Objective: The objective of this study is to assess the efficacy of skin anesthesia using fractional laser assisted delivery of articaine hydrochloride 40 mg/ml and epinephrine 10 µg/ml solution (AHES) compared to standard anesthesia with topical eutectic mixture of lidocaine 25 mg/g and prilocaine 25 mg/g cream (EMLA cream).

Study design: Prospective, open label, randomized controlled, within subject, study.

Study population: patients >18 years, who give written informed consent, visiting the institute for fractional carbon dioxide laser treatment for acne scars or traumatic scars.

Intervention (if applicable): In each patient, the lesional area will be divided into two comparable regions during the visit prior to the (next) fractional laser treatment. These regions will then be randomly allocated to either standard anesthesia with EMLA cream (control region; region I) or ablative fractional laser (AFXL) assisted delivery of AHES (intervention region; region II). Patients will be asked to apply EMLA cream at region I under occlusion two hours prior to the laser treatment. Fifteen minutes before the therapeutic laser treatment of the scars, the skin of region II will be pretreated with the fractional carbon dioxide laser (15% density, 2.5 mJ/microbeam). Directly following fractional laser pretreatment, AHES will be topically applied under occlusion at region II for 15 minutes. Subsequently treatment of both regions will be performed with the same fractional carbon dioxide laser at the settings used in routine clinical practice. Directly after this therapeutic laser treatment, patients will be asked to indicate pain per test region on a visual analogue scale (VAS) from 0-10 (0: no pain; 10: worst imaginable pain).

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1105AZ
        • Netherlands Institute for Pigment Disorders

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with acne scars or traumatic scars scheduled for treatment with the fractional carbon dioxide laser
  • Age ≥18 years
  • Patient is willing and able to give written informed consent

Exclusion Criteria:

  • Known allergy to local anesthesia
  • Pregnancy or lactation
  • Incompetency to understand what the procedure involves
  • Current complaints of chronic pain or other alterations in pain sensation (e.g. due to diabetes mellitus or lepra)
  • Current treatment with systemic analgesics or other medication that can influence pain sensation
  • Total lesional area to be treated in one session >600 cm2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Region 1
Standard topical anesthesia using eutectic mixture of lidocaine 25 mg/g and prilocaine 25 mg/g cream (EMLA cream) applied two hours before treatment.
Drug: EMLA cream
Topical application 2 hours prior to the treatment.
Other Names:
  • lidocaine 25 mg/g + prilocaine 25 mg/g cream
Experimental: Region 2
Anesthesia using articaine hydrochloride 40 mg/ml and epinephrine 10 µg/ml solution (AHES) applied on ablative fractional laser (AFXL) pretreated skin 15 minutes prior to the treatment.
Device: AFXL
Pretreatment at 2.5 mJ/microbeam and 15% density.
Other Names:
  • Fractional carbon dioxide laser
  • Ablative fractional laser
  • Fractional CO2 laser
  • UltraPulse®, DeepFx handpiece; Lumenis Inc.
Drug: AHES
Topical application on AFXL pretreated skin 15 minutes prior to the treatment.
Other Names:
  • articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml
  • Ultracain DS Forte

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain, as scored on a VAS from 0-10 (0: no pain; 10: worst imaginable pain) at each of both regions.
Time Frame: < 1 minute after AFXL treatment
< 1 minute after AFXL treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Netherlands Institute for Pigment Disorders

Investigators

  • Principal Investigator: Albert Wolkerstorfer, MD, PhD, Netherlands Institute for Pigment Disorders, Department of Dermatology, Academic Medical Center, University of Amsterdam
  • Study Director: Menno A. De Rie, MD, PhD, Department of Dermatology, Academic Medical Center, University of Amsterdam

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

September 4, 2015

First Submitted That Met QC Criteria

September 11, 2015

First Posted (Estimate)

September 14, 2015

Study Record Updates

Last Update Posted (Actual)

March 13, 2019

Last Update Submitted That Met QC Criteria

March 11, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL49394.018.14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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